The completeness, consistency and accuracy of data is essential in today’s data-driven decision making. This is particularly important during the characterization and validation of thermal processes that have potential to impact the quality, safety, and efficacy of drugs.
When reviewing these attributes as part of the auditing process, regulatory agencies expect drug manufacturer’s data to be reliable and accurate.
The increase in data integrity related observations over recent years has prompted regulatory agencies around the world to issue additional guidance clarifying the role of data integrity in current good manufacturing practice. Data integrity refers to the extent to which all data are complete, consistent and accurate. Key data attributes are summarized by the acronym
ALCOA
:
Attributable
,
Legible
,
Contemporaneous
,
Original
, and
Accurate
.
These expectations extend throughout the data lifecycle.
As a manufacturer of thermal validation systems for the life sciences industry, Lives International has incorporated these concepts into the design of the
XpertLog software
.
The software is used in conjunction with
Lives International thermal validation systems, Tc based and wireless data loggers
for the
acquisition
,
analysis
,
review
,
reporting
,
and storage
of thermal validation data. It utilizes user-defined acceptance criteria to evaluate data and provide a pass or fail determination without the need to leave the validated environment to export data to spreadsheets or perform manual calculations.
Major pharmaceutical and biotech companies do trust Lives International when it comes to ensure the highest level of Data Integrity using our 21 CFR Part 11 compliant software.
Schedule a site visit for a demo with our systems at
www.lives-international.com
to learn more about our XpertLog software and thermal validation systems.
